Company: Kelly Services
Posted on: September 14, 2019
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-- -- -- -- -- -- -- -- -- -- -- -- -- -- Supplier Auditor,
Jacksonville, Florida -- Kelly Services is currently seeking
a--Supplier Auditor--for one of our top clients in Jacksonville,
Florida. Our client is well known as one of the largest, most
innovative medical device and solutions, in orthopaedics, spinal
care, vision and neuroscience, in the world today.-- As a--Supplier
Auditor--placed with Kelly Services you will be responsible for:
Key Responsibilities Ensures effective supplier quality audit
program.-- Ensures effective Regulatory Health Authority Readiness
program for key critical suppliers. Accountable for the proactive
identification and alerting of quality issues in time to resolve
potential adverse effects to the customer, company image/reputation
and/or the business.-- Accountable for facilitating effective and
successful regulatory agency inspections. Essential Duties and
Responsibilities (Other duties may be assigned):
- Develops and executes organizational and operational policies
for the supplier quality audit program.
- Ensures adherence to approved supplier audit schedule.
- Conducts supplier audits and gap assessments in support of the
supplier quality audit program and regulatory health inspection
- Ensures audit reports are issued within the prescribed time
- Reviews, classifies observations, and approves audit
- Timely and accurately issues and maintain files associated with
supplier and EM audits, re audits and corrective action responses,
and performs updates in the applicable audit tracking systems.
- Monitors supplier quality audit program performance through the
use of trending and metrics.
- Provides advice and guidance to auditors.
- Manages external auditors/contract resources and approves
- Assists with responses to audit findings and other GMP/QMS
related issues as needed.
- Supports base business projects and initiatives, as
- Maintains abreast of regulatory changes through industry
publications, seminars, participation in trade organizations, and
government meetings. Assesses proposed regulations and communicates
new requirements to the organization.
- Follows all company guidelines related to Health, Safety and
Environmental practices and that all resources needed to do so are
available and in good
-- Education and/or Required Experience:
- BS in a related science or engineering field of study; and 8 or
more years of related experience and/or training; or MS with 6 or
more years; or Ph.D. with 4 or more years; or equivalent
combination of education and experience.
- Demonstrated compliance experience in domestic and/or
international quality systems.
- Experience dealing with applicable Health Authority
- The position will require approximately 25% domestic travel.--
The ability to drive and to be comfortable with air travel are
absolute requirements. -- Other Skills and Abilities:
- Good written and oral English communication skills.
- Ability to read, analyze and interpret scientific and technical
journals, financial reports, and legal documents.
- Strong understanding in FDA CFR Parts 11, 210, 211, and 820,
ICH Q7, ISO 13485 and/or other applicable regulations. Strong
knowledge of quality and compliance in a regulated GxP/QMS
- Ability to take in the vital points of the audit and make big
picture decisions and observations.
- Ability to select, manage and direct a team for/during an
audit, as applicable.
- Ability to respond to common inquiries, regulatory agencies, or
members of the business community.
- Statistical skills and manufacturing process
- Ability to lead a team through a root cause analysis
- Ability to effectively present information to management,
public groups, and/or boards of directors.--
- Engages in constructive conflict.
- High tolerance for ambiguity in a complex environment. Ability
to solve practical problems and deal with a variety of concrete
variables in situations where only limited standardization
- Ability to build partnerships both internally and externally.
Ability to effectively interface with governmental and independent
- Ability to use PC's and associated Microsoft software.
- Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and
trainings are preferred. This is a long-term open-ended
opportunity, typically multi-year.--This opportunity also offers
an--enhanced benefits package--from Kelly Services which
includes--401K participation, health insurance, PTO, and paid
holidays. Important information:--This position is recruited for by
a remote Kelly office, not your local Kelly branch.----Applicants
must be legally permitted to work in the United States
immediately--and without employer sponsorship--(F1 OPT cannot be
considered for this position).---- Why Kelly--? The Managed
Solutions practice within Kelly Outsourcing and Consulting Group
(KellyOCG--) is one focus within the full array of Kelly Services--
workforce solutions. Kelly Services has transformed from the
staffing industry pioneer to a leading workforce solutions
provider. KellyOCG is the distinguished outsourcing and consulting
segment of Kelly Services, known for applying a forward-looking
approach that enables companies to make strategic workforce
planning decisions that impact their business and competitive
advantage. The Managed Solutions practice area of KellyOCG is
dedicated to partnering with clients to architect and implement
solutions that put them in a position to meet their operational
obligation to their organization and freedom to focus on their more
strategic business needs. As a Kelly Services employee, you will
have access to numerous perks, including:
- Vacation and sick pay
- Paid holidays
- 401(k) plan
- Group medical, vision, dental, life, and short-term disability
- Kelly Discounts on goods and services, auto and home insurance,
and tuition at Kelly partner schools
- Kelly Learning Center offers free courses and trainings
- Weekly pay About Kelly Services-- As a workforce advocate for
over 70 years, we are proud to have a role in managing employment
opportunities for more than one million workers around the globe.
We employ 550,000 of these individuals directly with the remaining
workers engaged through our talent supply chain network of supplier
partners. Revenue in 2015 was $5.5 billion.
Visit--kellyservices.com--and connect with us
on--Facebook,--LinkedIn--and--Twitter. Kelly Services is an equal
opportunity employer including, but not limited to, Minorities,
Females, Individuals with Disabilities, Protected Veterans, Sexual
Orientation, Gender Identity and is committed to employing a
diverse workforce.--Equal Employment Opportunity is The Law. -- --
-- -- --Why Kelly--? Kelly puts you in charge of your career, with
access to cutting edge projects and technologies in industry
leading organizations. Top companies throughout the world have
trusted Kelly as a premier source of engineering talent and
services since 1965. And engineering job seekers know Kelly as a
firm with an unmatched reputation for quality, integrity, and
professionalism. Whether you seek the variety and flexibility of
working on short-term project engagements or prefer
contract-to-hire or direct-hire placement with our clients, apply
with Kelly to explore opportunities that suit your specific
professional interests. About Kelly-- At Kelly, we???re always
thinking about what???s next and advising job seekers on new ways
of working to reach their full potential. In fact, we???re a
leading advocate for temporary/nontraditional workstyles, because
we believe they allow flexibility and tremendous growth
opportunities that enable a better way to work and live. Connecting
great people with great companies is what we do best, and our
employment opportunities span a wide variety of workstyles, skill
levels, and industries around the world. Kelly is an equal
opportunity employer committed to employing a diverse workforce,
including, but not limited to, minorities, females, individuals
with disabilities, protected veterans, sexual orientation, gender
identity. Equal Employment Opportunity is The Law.
Keywords: Kelly Services, Jacksonville , Supplier Auditor, Other , Jacksonville, Florida
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